search
Back to results

Effect of Tibial Transcutaneous Electrostimulation in Women With Urgency Urinary Incontinence (TibialTNS)

Primary Purpose

Urinary Incontinence, Urge

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION
behavioral therapy protocol
Sponsored by
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring urinary incontinence, Sleep, nocturia, sedentary behavior, anxiety, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female sex;
  • Age from 18 years old;
  • Diagnosis of urgency urinary incontinence or mixed urinary incontinence
  • Score greater than or equal to 8 on the Hyperactive Bladder - Validated 8 Question Awareness Tool (OAB-V8)

Exclusion Criteria:

  • -Active urinary infection in the last four weeks;
  • Alcoholism, smoking or drug addiction;
  • Lesions and alteration of skin sensitivity in the place where electrotherapy will be applied;
  • Drug and/or physiotherapeutic treatment for urgency urinary incontinence;
  • Use of sleep-inducing medication,
  • Any neurological disease (multiple sclerosis, Alzheimer's disease, stroke and Parkinson's disease);
  • Use of anticholinergic drugs, calcium antagonists, b-antagonists and dopamine antagonists;
  • Presence of pelvic organ prolapse (POP), measured by a score greater than III by the POP-Q system;
  • Any comprehension difficulty or cognitive deficit that makes it impossible to carry out the research;
  • Gestational or puerperal period.

Sites / Locations

  • Instituto de medicina integral fernando figueiraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy

GS (Sham-sham group): Behavioral therapy

Arm Description

EG (experimental group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. In addition, patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a DUALPEX 961s electrical stimulation device (Quark, Brazil).

GS (Sham-sham group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. Twelve sessions will be held, twice a week, on non-consecutive days. The electrodes of the DUALPEX 961 equipment will be positioned one immediately posterior to the lateral malleolus of the ankle and the other approximately 30 cm above it, where there is no stimulus for the tibial nerve.

Outcomes

Primary Outcome Measures

Nocturia
People with an overactive bladder can experience nocturia, which means they need to get up frequently at night to go to the bathroom. Nocturia will be evaluated through the voiding diary that the volunteers will be instructed to complete. The more times the volunteer gets up at night to urinate, the more severe the condition.

Secondary Outcome Measures

sleep quality
Assessed by the Pittsburgh Sleep Quality Index (PSQI), with the global score ranging from 0 to 21. The higher, the worse the sleep quality.
physical activity level
lifestyle based on the daily number of steps
sedentary behavior
lifestyle based on the daily number of steps
anxiety level
A mental health disorder characterized by feelings of worry, anxiety, or fear that are strong enough to interfere with daily activities. Screening for study anxiety will be performed using the the Hospital Anxiety and Depression Scale (HADS). The scale is validated for Portuguese and was developed to identify possible cases of anxiety and depression through a structured and easy-to-apply questionnaire.The HADS consists of two subscales of 14 varied questions: 7 questions that measure anxiety (HADS-A) and 7 that measure depression (HADS-D). Each question has four possible answers and a score from 0 to 3 is given. The total score is then calculated and can range between 0 and 21 points on each subscale, with a higher score indicating more severe symptoms. The cut-off score for "possible cases" of anxiety and depression is 8 points or higher, which is the cut-off identified to provide the optimal balance between specificity and sensitivity.
Sleep parameters - Total time of sleep
Total time the individual spent sleeping during the night
Excessive daytime sleepiness
discrete quantitative variable, assessed using the Epworth sleepiness scale 1 ( ) yes, 2 ( ) no. It is a self-administered questionnaire and refers to the possibility of napping in eight everyday situations.
Severity of urinary incontinence
To identify how much the urinary incontinence impacts one's life.The severity of UI will be assessed using the Incontinence Severity Index (ISI), translated and validated into Portuguese by Pereira et al, in 2011 (Appendix 1)(126). This instrument consists of two questions regarding the frequency (1-4 points) and amount (1-3 points) of urinary loss. To obtain the final score, the scores for frequency of urinary leakage and the amount of urinary leakage are multiplied.
Life's quality
The SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36) is a generic instrument for assessing quality of life that is easy to administer and understand. It consists of a multidimensional questionnaire, consisting of 36 items, encompassed in 8 scales or domains. It has a final score from 0 to 100 (obtained by calculating the Raw Scale), where 0 corresponds to the worst general health status and 100 corresponds to the best health status.
Sleep parameters - sleep efficiency
Sleep efficiency is the relationship between the time the patient spent in bed and the actual sleep time.
Sleep parameters - Total time in bed
Total time in bed, whether sleeping or not.
Sleep parameters - Nightly awakenings
Number of times the individual wakes up during the night
Sleep parameters - Time awake after falling asleep
Time awake after sleep started, total time of nocturnal awakenings.

Full Information

First Posted
August 29, 2022
Last Updated
February 27, 2023
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
search

1. Study Identification

Unique Protocol Identification Number
NCT05590481
Brief Title
Effect of Tibial Transcutaneous Electrostimulation in Women With Urgency Urinary Incontinence
Acronym
TibialTNS
Official Title
Effect of Tibial Transcutaneous Electrostimulation in Women With Urgency Urinary Incontinence Compared to a Sham Group: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Urge urinary incontinence (UUI) is associated with nocturia, a common cause of sleep disorders, also related to levels of anxiety and depression. Studies demonstrate improvement in the clinical parameters of women with UUI after treatment with transcutaneous tibial nerve stimulation (TTNS). However, there are few data available on the association of urinary symptoms in women with UUI with sedentary behavior (SB), physical activity level (PAL) and sleep quality (SQ). Our study has the objective of evaluating the impact of TTNS on urinary symptoms, anxiety level, life quality(LQ), sleep parameters, PAL and SB in women with UUI.
Detailed Description
A randomized clinical trial, sham-controlled, comparing behavioral therapy and TTNS (intervention) to the use of behavioral therapy alone. It will include women with 18 years or more, diagnosed with UUI or mixed IU attested by the Questionnaire Overactive Bladder Validated 8 (OAB-V8). Women with active urinary tract infection in the last four weeks, alcoholics, smokers or drug addicts, with lesions and alteration of skin sensitivity in the place where electrotherapy will be applied, in drug and/or physiotherapeutic treatment for UUI or current OAB, using sleep-inducing medication, with any neurological disease, using anticholinergic drugs, calcium antagonists, antagonists and dopamine antagonists, with presence of pelvic organ prolapse, during pregnancy or puerperal or with any difficulty in understanding or cognitive deficit that makes it impossible to carry out the research will be excluded. Study variables are behavioral therapy, bilateral transcutaneous tibial nerve stimulation, type of UI, PAL, excessive daytime sleepiness, generic and specific LQ, SQ, UI severity, anxiety level, urinary frequency, nocturia and bladder capacity. Sample size was calculated, adopting a two-tailed test with the following parameters: α = 0.05, β = 0.20 and statistical power of 80% and 102 women will be included. The study will be carried out in two physiotherapy clinics in Recife, from September 2022 to June 2023, both groups will undergo a behavioral therapy protocol, (bladder training, pelvic floor muscle training and modification of liquid intake). Patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a electrical stimulation device (Quark, Brazil). The following parameters will be used for TTNS: frequency 10Hz (dez Hertz), pulse duration 200 μs (microseconds), for 30 minutes. In the experimental group, the electrodes will be positioned on the medial malleolus of both legs), in order to stimulate the tibial nerve path. In the Sham group, the electrodes will be placed on both legs, centered in the middle of the thigh, where there is no stimulus for the tibial or sacral nerve, for 30 minutes. The project was approved by the Research Ethics Committee of Professor Fernando Figueira Institute of Integral Medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
Keywords
urinary incontinence, Sleep, nocturia, sedentary behavior, anxiety, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy
Arm Type
Experimental
Arm Description
EG (experimental group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. In addition, patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a DUALPEX 961s electrical stimulation device (Quark, Brazil).
Arm Title
GS (Sham-sham group): Behavioral therapy
Arm Type
Sham Comparator
Arm Description
GS (Sham-sham group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. Twelve sessions will be held, twice a week, on non-consecutive days. The electrodes of the DUALPEX 961 equipment will be positioned one immediately posterior to the lateral malleolus of the ankle and the other approximately 30 cm above it, where there is no stimulus for the tibial nerve.
Intervention Type
Device
Intervention Name(s)
TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION
Intervention Description
The electrodes will be surface (silicone rubber and carbonate), brand Quark®, with dimensions of 5 cm by 3 cm, coupled with conductive gel and fixed to the volunteer's skin with micropore tape. For the placement of the electrodes, the volunteer will be positioned in the horizontal supine position on the stretcher, with the knee in semiflexion and the head supported on a pillow. The electrodes will be positioned one immediately posterior to the medial malleolus of the ankle and the other approximately 10 cm above it, both fixed with micropore tape, on both legs of the patient. To ensure that the electrodes stimulate the tibial nerve, a transcutaneous electrical nerve stimulation (TENS) current with a frequency of 1 Hz will first be applied, with a gradual increase in intensity, to verify a rhythmic movement of flexion of the hallux. The following parameters will be used for TTNS: frequency 10Hz (Hertz), pulse duration 200 μs (microseconds), for 30 minutes.
Intervention Type
Behavioral
Intervention Name(s)
behavioral therapy protocol
Intervention Description
submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene.
Primary Outcome Measure Information:
Title
Nocturia
Description
People with an overactive bladder can experience nocturia, which means they need to get up frequently at night to go to the bathroom. Nocturia will be evaluated through the voiding diary that the volunteers will be instructed to complete. The more times the volunteer gets up at night to urinate, the more severe the condition.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Secondary Outcome Measure Information:
Title
sleep quality
Description
Assessed by the Pittsburgh Sleep Quality Index (PSQI), with the global score ranging from 0 to 21. The higher, the worse the sleep quality.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
physical activity level
Description
lifestyle based on the daily number of steps
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
sedentary behavior
Description
lifestyle based on the daily number of steps
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
anxiety level
Description
A mental health disorder characterized by feelings of worry, anxiety, or fear that are strong enough to interfere with daily activities. Screening for study anxiety will be performed using the the Hospital Anxiety and Depression Scale (HADS). The scale is validated for Portuguese and was developed to identify possible cases of anxiety and depression through a structured and easy-to-apply questionnaire.The HADS consists of two subscales of 14 varied questions: 7 questions that measure anxiety (HADS-A) and 7 that measure depression (HADS-D). Each question has four possible answers and a score from 0 to 3 is given. The total score is then calculated and can range between 0 and 21 points on each subscale, with a higher score indicating more severe symptoms. The cut-off score for "possible cases" of anxiety and depression is 8 points or higher, which is the cut-off identified to provide the optimal balance between specificity and sensitivity.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Sleep parameters - Total time of sleep
Description
Total time the individual spent sleeping during the night
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Excessive daytime sleepiness
Description
discrete quantitative variable, assessed using the Epworth sleepiness scale 1 ( ) yes, 2 ( ) no. It is a self-administered questionnaire and refers to the possibility of napping in eight everyday situations.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Severity of urinary incontinence
Description
To identify how much the urinary incontinence impacts one's life.The severity of UI will be assessed using the Incontinence Severity Index (ISI), translated and validated into Portuguese by Pereira et al, in 2011 (Appendix 1)(126). This instrument consists of two questions regarding the frequency (1-4 points) and amount (1-3 points) of urinary loss. To obtain the final score, the scores for frequency of urinary leakage and the amount of urinary leakage are multiplied.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Life's quality
Description
The SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36) is a generic instrument for assessing quality of life that is easy to administer and understand. It consists of a multidimensional questionnaire, consisting of 36 items, encompassed in 8 scales or domains. It has a final score from 0 to 100 (obtained by calculating the Raw Scale), where 0 corresponds to the worst general health status and 100 corresponds to the best health status.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Sleep parameters - sleep efficiency
Description
Sleep efficiency is the relationship between the time the patient spent in bed and the actual sleep time.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Sleep parameters - Total time in bed
Description
Total time in bed, whether sleeping or not.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Sleep parameters - Nightly awakenings
Description
Number of times the individual wakes up during the night
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Title
Sleep parameters - Time awake after falling asleep
Description
Time awake after sleep started, total time of nocturnal awakenings.
Time Frame
Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female sex; Age from 18 years old; Diagnosis of urgency urinary incontinence or mixed urinary incontinence Score greater than or equal to 8 on the Hyperactive Bladder - Validated 8 Question Awareness Tool (OAB-V8) Exclusion Criteria: -Active urinary infection in the last four weeks; Alcoholism, smoking or drug addiction; Lesions and alteration of skin sensitivity in the place where electrotherapy will be applied; Drug and/or physiotherapeutic treatment for urgency urinary incontinence; Use of sleep-inducing medication, Any neurological disease (multiple sclerosis, Alzheimer's disease, stroke and Parkinson's disease); Use of anticholinergic drugs, calcium antagonists, b-antagonists and dopamine antagonists; Presence of pelvic organ prolapse (POP), measured by a score greater than III by the POP-Q system; Any comprehension difficulty or cognitive deficit that makes it impossible to carry out the research; Gestational or puerperal period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priscila Bezerra, MS
Phone
+5581988571614
Email
priscilabezerra1382@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julianna Guendler, PHD
Phone
+5581
Email
jujuguendler@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Katz, PHD
Organizational Affiliation
Instituto Materno Infantil Prof. Fernando Figueira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de medicina integral fernando figueira
City
Recife
State/Province
PE
ZIP/Postal Code
50070-902
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Souza
Phone
+558121224756
Email
comitedeetica@imip.org.br
First Name & Middle Initial & Last Name & Degree
Priscila Bezerra, MS
First Name & Middle Initial & Last Name & Degree
Julianna Guendler, Phd
First Name & Middle Initial & Last Name & Degree
Leila Katz, Phd
First Name & Middle Initial & Last Name & Degree
Melania Amorim, Phd
First Name & Middle Initial & Last Name & Degree
Anna Myrna Jaguaribe

12. IPD Sharing Statement

Learn more about this trial

Effect of Tibial Transcutaneous Electrostimulation in Women With Urgency Urinary Incontinence

We'll reach out to this number within 24 hrs